This study is a prospective, multicenter, open-label, phase II clinical trial designed to evaluate the safety and efficacy of moxibustion in patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT). A total of 42 patients with SR-aGVHD, primarily involving the gastrointestinal tract and presenting with abdominal pain and diarrhea, will be enrolled. All participants will receive standard second-line therapy based on best available treatment (BAT), including ruxolitinib, basiliximab, or methotrexate, according to clinical judgment. In addition, patients will receive moxibustion at specific acupoints (Tianshu \[ST25\], Shenque \[CV8\], and Qihai \[CV6\]) for 30 minutes once or twice daily for 28 days. The primary endpoint is the overall response rate (ORR) at Day 28. Secondary endpoints include durable ORR at Day 56, incidence and severity of chronic GVHD (cGVHD), non-relapse mortality (NRM), overall survival (OS), and changes in traditional Chinese medicine (TCM) syndrome scores. Safety will be assessed by monitoring adverse events throughout the study period. This study aims to explore whether moxibustion, as an adjunctive therapy, can improve clinical outcomes and provide a safe and effective treatment strategy for patients with SR-aGVHD after allo-HSCT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Moxibustion applied at Tianshu (ST25), Shenque (CV8), and Qihai (CV6), 30 minutes once daily for 28 days.
Moxibustion applied at Tianshu (ST25), Shenque (CV8), and Qihai (CV6), 30 minutes twice daily for 28 days.
Investigator-selected second-line therapy for SR-aGVHD, including ruxolitinib, basiliximab, or methotrexate.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGOverall Response Rate (ORR) at Day 28
Overall response rate (ORR) is defined as the proportion of participants achieving complete response (CR) or partial response (PR) according to established criteria for acute graft-versus-host disease.
Time frame: Day 28
Durable Overall Response Rate (ORR) at Day 56
Time frame: Day 56
Incidence and Severity of Chronic Graft-Versus-Host Disease (cGVHD)
Incidence and severity of chronic GVHD assessed according to standard clinical criteria.
Time frame: Up to 180 days
Non-Relapse Mortality (NRM)
Death without prior relapse of the underlying disease.
Time frame: Up to 180 days
Overall Survival (OS)
Time from enrollment to death from any cause.
Time frame: Up to 180 days
Traditional Chinese Medicine (TCM) Syndrome Score
Changes in TCM syndrome scores based on predefined criteria for spleen-kidney yang deficiency.
Time frame: Baseline, Day 14, Day 28, Day 56, Day 90, Day 180
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